Evidence map›Paper›PMID 42885177›Full record

ArticleStatistics in medicine2026

Semantic Similarity-Informed Bayesian Borrowing for Quantitative Signal Detection of Adverse Events.

François Haguinet, Jeffery L Painter, Gregory E Powell, Andrea Callegaro, Andrew Bate

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In one paragraph

Article in Statistics in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

François HaguinetGSK, Wavre, Belgium.ORCID https://orcid.org/0000-0003-4989-3738
Jeffery L PainterGSK, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0001-9651-9904
Gregory E PowellGSK, Durham, North Carolina, USA.
Andrea CallegaroGSK, Wavre, Belgium.ORCID https://orcid.org/0000-0003-4805-5118

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We present a Bayesian dynamic borrowing approach to enhance quantitative identification of adverse events in spontaneous reporting systems. The method embeds a robust meta-analytic predictive prior and incorporates semantic similarity measures (SSMs) to enable weighted information sharing from clinically similar MedDRA preferred terms (PTs) to the target PT. This continuous similarity-based borrowing overcomes limitations of rigid hierarchical grouping in disproportionality analysis (DPA). Using data from the FDA Adverse Event Reporting System and a time-stamped reference set, we evaluate our approach-termed IC SSM-against the current standard approach of "traditional" information component (IC) analysis and borrowing at the MedDRA HLGT level (IC HLGT). The primary IC SSM approach at the standard threshold (2.5% posterior quantile

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsSemanticsBayes TheoremHumansSensitivity and SpecificityUnited StatesUnited States Food and Drug AdministrationBayesian borrowingdrug safetypharmacovigilancesemantic similaritysignal detection

Identifiers

PMID42885177

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.